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510(k) K823733

EIKEN KIZAI ARTIFICIAL KIDNEY BLOOD CIR by Advocacy International, Ltd. — Product Code KOC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 1983
Date Received
December 13, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Blood Circuit, Hemodialysis
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances by Advocacy International, Ltd.

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  • K855212 — ASAHI AM SERIES DIALYZERS (January 21, 1986)
  • K854259 — SEPACELL R-500 & SEPACELL R-500A (January 8, 1986)
  • K842103 — TOYO JOZO URIC ACID TEST (August 12, 1984)
  • K842104 — TOYO JOZO G-GTP TEST (August 10, 1984)
  • K830183 — ASAHI HOLLOW FIBER KIDNEYS NR SERIES (March 17, 1983)
  • K830231 — ASAHI HOLLOW FIBER KIDNEYS, AM-SERIES (March 17, 1983)
  • K813037 — FLOWGUARD CATHETERS & CANNALAE (December 14, 1981)

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